CN1895401A - Preparation of kidney-tonifying health-care tablet by micropowder technology - Google Patents

Preparation of kidney-tonifying health-care tablet by micropowder technology Download PDF

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Publication number
CN1895401A
CN1895401A CN 200610018006 CN200610018006A CN1895401A CN 1895401 A CN1895401 A CN 1895401A CN 200610018006 CN200610018006 CN 200610018006 CN 200610018006 A CN200610018006 A CN 200610018006A CN 1895401 A CN1895401 A CN 1895401A
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powder
granule
mix homogeneously
dry
chinese medicinal
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CN100518770C (en
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杨士伟
蔡俊安
王云东
郭鑫慧
张祥俊
鲁张彦
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Henan Bainian Kangxin Pharma Co., Ltd.
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KANGXIN PHARMACEUTICAL CO Ltd HENAN
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Abstract

A process for preparing the tablet to nourish kidney and building up body includes such steps as washing, baking and mixing of epimedium and scythian lamb rhizome, pulverizing, sieving, sterilizing, decocting epimedium, cherokee rose-hip and lucid ligustrum fruit twice, filtering, concentrating, mixing it with said fine powder, drying, pulverizing, granulating, mixing with lubricant, stirring, die pressing and coating.

Description

Utilize the preparation method of micropowder technology production BUSHEN QIANGSHEN PIAN
One, technical field
The present invention relates to field of medicaments, particularly a kind of preparation method of utilizing micropowder technology production BUSHEN QIANGSHEN PIAN.
Two, background technology
BUSHEN QIANGSHEN PIAN is a kind of classical Chinese patent medicine, has the kidney-tonifying health-care effect, is used for that soreness of waist foot is soft, dizziness and tinnitus, dim eyesight cardiopalmus, impotence and seminal emission.Be Chinese medicine Rhizoma Cibotii (system), Semen Cuscutae powder to be broken into fine powder (crossing the sieve of sieve aperture internal diameter 180 μ m) directly be used as medicine among the preparation technology, be widely used in the clinical treatment of insufficiency of kidney-YANG, but in clinical practice, part patient reflect that curative effect is undesirable.
Three, summary of the invention
The objective of the invention is at the pharmaceutical effectiveness of patient's reflection undesirable, and a kind of preparation method of utilizing micropowder technology production BUSHEN QIANGSHEN PIAN that provides, thereby improved the stripping of ingredient, improved clinical efficacy, overcome the low problem of pharmaceutical effectiveness, the objective of the invention is to realize by following scheme:
This BUSHEN QIANGSHEN PIAN is to be made by Herba Epimedii, Rhizoma Cibotii (system), Semen Cuscutae, Fructus Rosae Laevigatae, Fructus Ligustri Lucidi and lubricant, and its preparation method is:
With Rhizoma Cibotii (system) and Semen Cuscutae respectively water wash towards drip washing, place respectively in the exsiccator after cleaning, dry, mix two kinds of medical materials, with pulverizer pulverizing medicinal materials is become Chinese medicinal powder, and can pass through the sieve of sieve aperture internal diameter 75 μ m, stand-by after fully mixing, sterilizing again; With YINYANGCHUAN; Fructus Rosae Laevigatae; Fructus Ligustri Lucidi decocts with water twice, filters, and merges filtrate twice; be condensed into thick paste, with behind above-mentioned Chinese medicinal powder and the thick paste mix homogeneously, put in the exsiccator again; carry out drying, dried dried cream powder is broken to the dried cream powder end of 60-100 mesh sieve, powder is made granule with ethanol or water; drying, by 12-16 mesh sieve grain, the adding mix lubricant is even; compacting in flakes; coating or with the dried cream powder end with dry granulation mechanism grain, add lubricant, mix homogeneously; be pressed into tablet; pass through coating again or with thick paste through super-dry, be ground into 60-100 mesh sieve powder, with the Chinese medicinal powder mix homogeneously; make granule with ethanol or water; granule is crossed 12-16 mesh sieve granule through super-dry, and the adding mix lubricant is even; be pressed into tablet; again through coating or with making granule behind thick paste and the Chinese medicinal powder mix homogeneously, drying is by 12-16 mesh sieve grain; it is even to add mix lubricant; compacting is in blocks, coating, promptly.
Prescription science of the present invention, method advanced person particularly utilizes micropowder technology, has improved the quality and the curative effect of medicine, is the inventive improvements to existing BUSHEN QIANGSHEN PIAN.
Four, the specific embodiment
Below in conjunction with concrete condition and embodiment the specific embodiment of the present invention is elaborated.
Provided by technique scheme, BUSHEN QIANGSHEN PIAN of the present invention is prepared from by weight percentage by following composition: Herba Epimedii 27-33%, and Rhizoma Cibotii (system) 15-19%, Semen Cuscutae 15-19%, Fructus Rosae Laevigatae 15-19%, Fructus Ligustri Lucidi 15-19%, wherein:
1, with Rhizoma Cibotii (system) and Semen Cuscutae respectively water wash towards drip washing, put in the exsiccator respectively after cleaning, adjust temperature and under 70-90 ℃, carry out drying, taking by weighing two kinds of medical materials by above-mentioned weight ratio mixes, be ground into Chinese medicinal powder, and sieve that can be by sieve aperture internal diameter 75 μ m, behind abundant mix homogeneously, stand-by after sterilizing 20-40 minute under the 110-130 ℃ of condition again;
2, Herba Epimedii, Fructus Rosae Laevigatae, Fructus Ligustri Lucidi are weighed by above-mentioned weight ratio, add 6-10 times of water gaging and decocted 1.5-2.5 hour, decoct twice, decoction liquor merges after filtering, and filtrate is through being concentrated into the thick paste that density is 1.15-1.35 (at 60-80 ℃ of conditioned measurement);
3, above-mentioned Chinese medicinal powder and thick paste are mixed after, put in the exsiccator, adjust temperature and under 60-90 ℃ of condition, carry out drying, dried dried cream powder is broken to the dried cream powder end of 60-100 mesh sieve, powder is made granule with ethanol or water, granule is through super-dry, by 12-16 mesh sieve granulate, (lubricant is magnesium stearate or Pulvis Talci to the lubricant of the 0.25-6% of adding particle weight, and wherein magnesium stearate is the 0.25-1% of particle weight, and Pulvis Talci is the 3-6% of particle weight, as follows) mix homogeneously, be pressed into tablet, pass through coating again, promptly;
Or with the dried cream powder end through dry granulation mechanism grain, add lubricant (the 0.25-1% magnesium stearate of particle weight or 3-6% Pulvis Talci) mix homogeneously, be pressed into tablet, pass through coating again, promptly;
Or with above-mentioned thick paste through super-dry, be ground into 60-100 mesh sieve powder, with the Chinese medicinal powder mix homogeneously, make granule with ethanol or water, granule is through super-dry, by 12-16 mesh sieve granulate, add lubricant (the 0.25-1% magnesium stearate of particle weight or 3-6% Pulvis Talci) mix homogeneously, be pressed into tablet, pass through coating again, promptly;
Or make granule after evenly with extractum and powder mixes, drying by 12-16 mesh sieve granulate, adds lubricant (the 0.25-1% magnesium stearate of particle weight or 3-6% Pulvis Talci) mix homogeneously, is pressed into tablet, passes through coating again, promptly.
Embodiment 1
(1), with Rhizoma Cibotii (system) and Semen Cuscutae respectively water wash towards drip washing, put in the exsiccator respectively after cleaning, adjust temperature and under 80 ℃, carry out drying, get Rhizoma Cibotii (system) 970 grams, Semen Cuscutae 970 grams mix two kinds of medical materials, be ground into Chinese medicinal powder with pulverizer, and sieve that can be by sieve aperture internal diameter 75 μ m, behind the abundant mix homogeneously of mixing machine, stand-by after 30 minutes again in sterilization under 120 ℃ of conditions;
(2), get Herba Epimedii 1610 grams, Fructus Rosae Laevigatae 970 grams, Fructus Ligustri Lucidi 970 grams, the water 35500ml that adds 10 times of amounts decocted 2 hours, filter the back and preserve decoction liquor, the water 21300ml that medicinal residues add 6 times of amounts decocted 1.5 hours, merge twice filtrate after filtering, filtrate is through being concentrated into the thick paste that density is 1.25 (measuring) under 80 ℃ of conditions;
(3), above-mentioned Chinese medicinal powder and thick paste are mixed after, put in the exsiccator, adjust temperature and under 80 ℃ of conditions, carry out drying, dried dried cream powder is broken to the dried cream powder end of 80 mesh sieves, granule is made with ethanol or water in the dried cream powder end, ethanol or water addition be dried cream powder end bulking value 30% (weight is in gram, volume is in ml, as follows), granule is through super-dry, by 14 mesh sieve granulate, the 1% magnesium stearate mix homogeneously that adds particle weight, be pressed into tablet, pass through coating again, promptly;
Embodiment 2:
(1), with Rhizoma Cibotii (system) and Semen Cuscutae respectively water wash towards drip washing, put in the exsiccator respectively after cleaning, adjust temperature and under 80 ℃, carry out drying, get Rhizoma Cibotii (system) 970 grams, Semen Cuscutae 970 grams mix two kinds of medical materials, be ground into Chinese medicinal powder with pulverizer, and sieve that can be by sieve aperture internal diameter 75 μ m, behind the abundant mix homogeneously of mixing machine, stand-by after 30 minutes again in sterilization under 120 ℃ of conditions;
(2), get Herba Epimedii 1610 grams, Fructus Rosae Laevigatae 970 grams, Fructus Ligustri Lucidi 970 grams, the water 35500ml that adds 10 times of amounts decocted 2 hours, filter the back and preserve decoction liquor, the water 21300ml that medicinal residues add 6 times of amounts decocted 1.5 hours, merge twice filtrate after filtering, filtrate is through being concentrated into the thick paste that density is 1.25 (measuring) under 80 ℃ of conditions;
(3), above-mentioned Chinese medicinal powder and thick paste are mixed after; put in the exsiccator; adjust temperature and under 80 ℃ of conditions, carry out drying; get dry extract, dried cream powder is broken into 80 mesh sieve powder, through dry granulation mechanism grain; the 1% magnesium stearate mix homogeneously that adds particle weight; be pressed into tablet, pass through coating again, promptly.
Embodiment 3:
(1), with Rhizoma Cibotii (system) and Semen Cuscutae respectively water wash towards drip washing, put in the exsiccator respectively after cleaning, adjust temperature and under 80 ℃, carry out drying, get Rhizoma Cibotii (system) 970 grams, Semen Cuscutae 970 grams mix two kinds of medical materials, be ground into Chinese medicinal powder with pulverizer, and sieve that can be by sieve aperture internal diameter 75 μ m, behind the abundant mix homogeneously of mixing machine, stand-by after 30 minutes again in sterilization under 120 ℃ of conditions;
(2), get Herba Epimedii 1610 grams, Fructus Rosae Laevigatae 970 grams, Fructus Ligustri Lucidi 970 grams, the water 35500ml that adds 10 times of amounts decocted 2 hours, filter the back and preserve decoction liquor, the water 21300ml that medicinal residues add 6 times of amounts decocted 1.5 hours, merge twice filtrate after filtering, filtrate is through being concentrated into the thick paste that density is 1.25 (measuring) under 80 ℃ of conditions;
(3), above-mentioned thick paste is put in the exsiccator, adjust temperature and under 80 ℃ of conditions, carry out drying, get dry extract, dried cream powder is broken into the powder of 80 mesh sieves, with above-mentioned Chinese medicinal powder mix homogeneously, make granule with ethanol, granule is through super-dry, by 14 mesh sieve granulate, the Pulvis Talci mix homogeneously that adds particle weight 3%, be pressed into tablet, pass through coating again, promptly.
The system Rhizoma Cibotii that said Rhizoma Cibotii (system) is promptly concocted by the Chinese medicine processing requirement in above-mentioned each component.
From the above, the present invention utilizes the micropowder technology processing and preparing to form in Chinese medicine, through clinical trial and mensuration, than original medicine substantial improvement and significant curative effect is arranged, and its clinical data is as follows:
One, select the standard of case:
Every at outpatient service or inpatient, have the feature of nephropathy such as waist soreness, dizziness and tinnitus, dim eyesight cardiopalmus, impotence and seminal emission, lassitude, all as the standard of selecting case.
Two, diagnostic criteria
Primary symptom: soreness of the waist and knees, hyposexuality, aversion to cold and cold limbs.
Inferior disease: lethargy, nocturia, edema of lower limbs, moving then tachypnea, the dried and withered hairs luxated tooth, the pale tongue tongue is white, deep-slow pulse, unable.
Possess 2 of above primary symptoms, 2 of inferior diseases, can diagnose sick for this reason.
Three, therapeutic scheme
5 of the each clothes of patient, every 0.25g, obey every day 3 times, one month is a course of treatment, carry out the curative effect inspection after one month, and establish matched group and contrast treatment, the present invention is broken into powder (and can by sieve aperture internal diameter 75 μ m sieve) with Rhizoma Cibotii (system), Semen Cuscutae powder, and the BUSHEN QIANGSHEN PIAN of making (the present invention claims the micropowder BUSHEN QIANGSHEN PIAN) and Rhizoma Cibotii (system), Semen Cuscutae powder are broken into the BUSHEN QIANGSHEN PIAN (claiming common BUSHEN QIANGSHEN PIAN) that powder (also can by the sieve of sieve aperture internal diameter 180 μ m) makes and compare.
Four, efficacy assessment standard
Recovery from illness: clinical symptoms, sign disappear or basic the disappearance; The syndrome integration reduces 〉=95%
Produce effects: clinical symptoms, sign are obviously improved, and the syndrome integration reduces 〉=70%
Effectively: clinical symptoms, sign all take a favorable turn, and the syndrome integration reduces 〉=30%
Invalid: clinical symptoms, sign do not have obvious improvement, and the syndrome integration reduces less than 30%
Computing formula (nimodipine method) is: [integration before (integration before the treatment-treatment back integration) ÷ treatment] * 100%
Five, statistical disposition
Through 71 nephrotics are compared treatment, random packet, medicine group 34 people wherein of the present invention, contrast groups 37 people take by therapeutic scheme and to check after one month, by its symptom scalar quantization weighting score value, carry out the curative effect observed result, add up, as following table:
Clinical effectiveness Case Recovery from illness Produce effects Effectively Invalid Total effective rate (%)
Common BUSHEN QIANGSHEN PIAN 34 8 11 10 5 85.3
The micropowder BUSHEN QIANGSHEN PIAN 37 11 15 9 2 94.6
The clinical effectiveness of micropowder BUSHEN QIANGSHEN PIAN obviously is better than common BUSHEN QIANGSHEN PIAN (P<0.01).
Why there were significant differences for two kinds of BUSHEN QIANGSHEN PIAN, Chinese medicinal powder composition stripping contrast experiment through two kinds of different degrees of grinding, show Chinese medicine Rhizoma Cibotii (system), Semen Cuscutae be mixed in proportion after, be ground into the Chinese medicinal powder of fine powder (can pass through the sieve of sieve aperture internal diameter 180 μ m) and micropowder (can pass through the sieve of sieve aperture internal diameter 75 μ m) respectively with pulverizer, two kinds of powder are carried out composition stripping contrast experiment, by 2005 editions appendix XA of Chinese Pharmacopoeia determination of extractives method (concentration of alcohol is 50%), the result is:
Powder Fine powder Micropowder
Water-soluble extractives (%) 19.2 28.6
Ethanol-soluble extractives (%) 16.7 24.4
By table as seen, the micropowder powder improves 9.4% than fine powder powder water-soluble extractives, and ethanol-soluble extractives improves 7.7%.Therefore Chinese medicine micropowder and Chinese medicine fine powder powder relatively have the Chinese medicine ingredients of promotion result of extraction, thereby have improved the Chinese medicine utilization rate of active components, have improved the treatment curative effect, and this is the place of micropowder technology creativeness in the present invention, also are that core of the present invention is with crucial.
Six, conclusion
By above-mentioned situation as can be seen, utilize BUSHEN QIANGSHEN PIAN that micropowder technology prepares in essence raising all to be arranged on quality and curative effect than common BUSHEN QIANGSHEN PIAN, not only effective ingredient is fully utilized, improved curative effect greatly, and opened kidney-tonifying health-care, improved new way of people's healthy quality, actual production and clinical meaning are arranged, have huge economic and social benefit.

Claims (4)

1, a kind of preparation method of utilizing micropowder technology production BUSHEN QIANGSHEN PIAN is characterized in that being, by by weight percentage: Herba Epimedii 27-33%, Rhizoma Cibotii (system) 15-19%, Semen Cuscutae 15-19%, Fructus Rosae Laevigatae 15-19%, Fructus Ligustri Lucidi 15-19% makes, wherein:
(1), with Rhizoma Cibotii (system) and Semen Cuscutae respectively water wash towards drip washing, put in the exsiccator respectively after cleaning, adjust temperature and under 70-90 ℃, carry out drying, taking by weighing two kinds of medical materials mixes, be ground into Chinese medicinal powder, cross the sieve of internal diameter 75 μ m, behind abundant mix homogeneously, sterilization is stand-by after 20-40 minute down at 115-130 ℃ again;
(2), Herba Epimedii, Fructus Rosae Laevigatae, Fructus Ligustri Lucidi added the decocting that 6-10 doubly measures boiled 1.5-2.5 hour, decoct twice altogether, decoction liquor merges after filtering, filtrate is through thick paste that to be concentrated into 80 ℃ of lower densities be 1.15-1.35;
(3); after above-mentioned Chinese medicinal powder and thick paste mixed; put in the exsiccator; adjust temperature and under 60-90 ℃ of condition, carry out drying; dried dried cream powder is broken to the dried cream powder end of 60-100 mesh sieve; powder is made granule with ethanol or water; granule is through super-dry; by 12-16 mesh sieve granulate, the mix lubricant of 0.25-6% that adds particle weight is even, be pressed into tablet or with the dried cream powder end through dry granulation mechanism grain; the mix lubricant of the 0.25-6% of adding particle weight is even; be pressed into tablet or with above-mentioned thick paste through super-dry, be ground into 60-100 mesh sieve powder, with the Chinese medicinal powder mix homogeneously; make granule with ethanol or water; granule is through super-dry, and by 12-16 mesh sieve granulate, the mix lubricant of the 0.25-6% of adding particle weight is even; be pressed into tablet or make granule after evenly with extractum and powder mixes; drying, by 12-16 mesh sieve grain, the mix lubricant of the 0.25-6% of adding particle weight is even; compacting is in blocks, through coating.
2, the preparation method of utilizing micropowder technology production BUSHEN QIANGSHEN PIAN according to claim 1, it is characterized in that, said Rhizoma Cibotii (system) and Semen Cuscutae granularity are the Chinese medicinal powder of 75 μ m, behind abundant mix homogeneously, sterilize 20-40 minute down at 115-130 ℃.
3, the preparation method of utilizing micropowder technology production BUSHEN QIANGSHEN PIAN according to claim 1 is characterized in that, said lubricant is hard magnesium or Pulvis Talci.
4, the preparation method of utilizing micropowder technology production BUSHEN QIANGSHEN PIAN according to claim 1 is characterized in that being:
(1), with Rhizoma Cibotii (system) and Semen Cuscutae respectively water wash towards drip washing, put in the exsiccator respectively after cleaning, adjust temperature and under 80 ℃, carry out drying, get Rhizoma Cibotii (system) 970 grams, Semen Cuscutae 970 grams mix two kinds of medical materials, pulverize Chinese medicinal powder with pulverizer, cross the sieve of internal diameter 75 μ m, after mixing machine fully mixed, sterilization was stand-by after 30 minutes down at 120 ℃ again;
(2), get Herba Epimedii 1610 grams, Fructus Rosae Laevigatae 970 grams, Fructus Ligustri Lucidi 970 grams, the water 35500ml that adds 10 times of amounts decocted 2 hours, filter the back and preserve decoction liquor, the water 21300ml that medicinal residues add 6 times of amounts decocted 1.5 hours, merge twice filtrate after filtering, filtrate is 1.25 thick paste (measuring under 80 ℃ of conditions) through being concentrated into density;
(3); after above-mentioned Chinese medicinal powder and thick paste mixed; put in the exsiccator; adjust temperature and under 80 ℃ of conditions, carry out drying; dried dried cream powder is broken to the dried cream powder end of 80 mesh sieves; powder is made granule with 30% ethanol; granule is through super-dry; by 14 mesh sieve granulate; add 1% hard magnesium mix homogeneously of particle weight or through dry granulation mechanism grain, add 1% hard magnesium mix homogeneously of particle weight or thick paste is dry and be crushed to the extractum powder and the Chinese medicinal powder mix homogeneously of 80 mesh sieves, make granule with 30% ethanol; granule is through super-dry; by 14 mesh sieve granulate, add 3% Pulvis Talci mix homogeneously of particle weight, or granulate behind above-mentioned Chinese medicinal powder and the thick paste mix homogeneously; granule is through super-dry; cross 14 mesh sieve granulate, the 3% Pulvis Talci mix homogeneously compacting that adds particle weight is in blocks, coating.
CNB2006100180067A 2006-06-26 2006-06-26 Preparation of kidney-tonifying health-care tablet by micropowder technology Active CN100518770C (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101011480B (en) * 2007-02-13 2011-08-31 美晨集团股份有限公司 Method for overall monitoring for kidney-tonifying body-strengthening tablet quality
CN102600397A (en) * 2012-04-09 2012-07-25 河南百年康鑫药业有限公司 Method for producing arthritis treatment tablet for treatment of arthritis via micro powder technology
CN102641303A (en) * 2011-02-18 2012-08-22 上海张江中药现代制剂技术工程研究中心 Method for preventing roller-bonding phenomenon of material during traditional Chinese medicine dry granulation process
CN105770076A (en) * 2016-02-28 2016-07-20 南京正亮医药科技有限公司 Preparation method and application of kidney nourishing and strengthening capsules
CN106177034A (en) * 2016-08-25 2016-12-07 陕西必康制药集团控股有限公司 A kind of preparation method of the medicament with kidney-tonifying health-care function

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101011480B (en) * 2007-02-13 2011-08-31 美晨集团股份有限公司 Method for overall monitoring for kidney-tonifying body-strengthening tablet quality
CN102641303A (en) * 2011-02-18 2012-08-22 上海张江中药现代制剂技术工程研究中心 Method for preventing roller-bonding phenomenon of material during traditional Chinese medicine dry granulation process
CN102641303B (en) * 2011-02-18 2015-07-08 上海张江中药现代制剂技术工程研究中心 Method for preventing roller-bonding phenomenon of material during traditional Chinese medicine dry granulation process
CN102600397A (en) * 2012-04-09 2012-07-25 河南百年康鑫药业有限公司 Method for producing arthritis treatment tablet for treatment of arthritis via micro powder technology
CN105770076A (en) * 2016-02-28 2016-07-20 南京正亮医药科技有限公司 Preparation method and application of kidney nourishing and strengthening capsules
CN106177034A (en) * 2016-08-25 2016-12-07 陕西必康制药集团控股有限公司 A kind of preparation method of the medicament with kidney-tonifying health-care function

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Address after: 477150 No. 168 Jinxing Road, Dancheng County, Zhoukou City, Henan Province

Patentee after: Henan Bainian Kangxin Pharma Co., Ltd.

Address before: 477150 No. 168 Jinxing Road, Dancheng County, Henan Province

Patentee before: Kangxin Pharmaceutical Co., Ltd., Henan